Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- BRWProtector, Dental1Product Code
- BSFAbsorber, Carbon-Dioxide1Product Code
- BSJMask, Gas, Anesthetic1Product Code
- BSKCuff, Tracheal Tube, Inflatable2Product Code
- BSNFilter, Conduction, Anesthetic2Product Code
- BSOCatheter, Conduction, Anesthetic2Product Code
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)2Product Code
- BSRStylet, Tracheal Tube1Product Code
- BSZGas-Machine, Anesthesia2Product Code
- BTBHook, Ether1Product Code
- BTCBag, Reservoir1Product Code
- BTKStrap, Head, Gas Mask1Product Code
- BTLVentilator, Emergency, Powered (Resuscitator)2Product Code
- BTMVentilator, Emergency, Manual (Resuscitator)2Product Code
- BTOTube, Tracheostomy (W/Wo Connector)2Product Code
- BTPDropper, Ether1Product Code
- BTQAirway, Nasopharyngeal1Product Code
- BTRTube, Tracheal (W/Wo Connector)2Product Code
- BTSTube, Bronchial (W/Wo Connector)2Product Code
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)2Product Code
- BWBForceps, Tube Introduction1Product Code
- BWCNeedle, Emergency Airway2Product Code
- BWFSpirometer, Therapeutic (Incentive)2Product Code
- BWLApparatus, Electronanesthesia3Product Code
- BYDCondenser, Heat And Moisture (Artificial Nose)1Product Code
- BYEAttachment, Breathing, Positive End Expiratory Pressure2Product Code
- K160112Besmed PEEP Valve2Cleared 510(K)
- K133957DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE2Cleared 510(K)
- K133210B&B BUBBLER2Cleared 510(K)
- K122610PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES2Cleared 510(K)
- K112546O_TWO CPAP SYSTEM2Cleared 510(K)
- K110713WATERPAP VALVE2Cleared 510(K)
- K103833NEOPIP PATIENT CIRCUIT WITH PEEP2Cleared 510(K)
- K092029VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP003102Cleared 510(K)
- K090710MERCURY CPAP2Cleared 510(K)
- K090317BABI*PLUS BUBBLE PAP VALVE2Cleared 510(K)
- K081266MERCURY MEDICAL PEEP VALVE2Cleared 510(K)
- K080256PULMODYNE CHF FLOW GENERATOR SYSTEM2Cleared 510(K)
- K070416NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP2Cleared 510(K)
- K050918KOO AMERICAS VALVE PEEP, MODEL KM-8092Cleared 510(K)
- K013884BOUSSIGNAC C.P.A.P. DEVICE2Cleared 510(K)
- K001318CPAP SYSTEM, MODEL 1020012Cleared 510(K)
- K982283WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH2Cleared 510(K)
- K983920EMS PEEP VALVES- ADJUSTABLE2Cleared 510(K)
- K9814150-20 CM H20 PEEP VALVE2Cleared 510(K)
- K963347REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 1422Cleared 510(K)
- K962492SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM2Cleared 510(K)
- K961867PEEP VALVE2Cleared 510(K)
- K955047WESTMED CIRCULARIE PEP DEVICES2Cleared 510(K)
- K953511KENDALL SHERIDAN CPAP SYSTEM2Cleared 510(K)
- K953485SIMS CPAP SYSTEM2Cleared 510(K)
- K950397SYSTEM 22 VALVE2Cleared 510(K)
- K942246PURITAN-BENNETT NASAL CPAP MASK2Cleared 510(K)
- K932799SINGLE USE MANUAL RESUSCITATOR PEEP VALVE2Cleared 510(K)
- K923976AMBU SINGLE PATIENT USE PEEP VALVE2Cleared 510(K)
- K923618PEEP VALVE2Cleared 510(K)
- K922178COMPANION 318 NASAL CPAP SYSTEM -- MODIFICATION2Cleared 510(K)
- K91257820CM/H20 PEEP VALVE2Cleared 510(K)
- K912240CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM2Cleared 510(K)
- K904874ADJUSTABLE PEEP VALVE2Cleared 510(K)
- K903764COMPANION 318 NASAL CPAP SYSTEM2Cleared 510(K)
- K903125PURITAN BENNETT SINGLE PATIENT USE PEEP VALVE2Cleared 510(K)
- K902062PEEP VALVE2Cleared 510(K)
- K901728ONE-LUNG CPAP DEVICE2Cleared 510(K)
- K900113RESPIRONICS' REMSTAR(TM) SLEEPEASY2Cleared 510(K)
- K900164AIRWAY DELIVERY & MANAGEMENT (ADAM) NASAL VENTILA.2Cleared 510(K)
- K894779LIFECARE NASAL MASK KIT CAT. NO. 06-8002Cleared 510(K)
- K895360C.P.A.P. VALVE AND C.P.P.A. KIT2Cleared 510(K)
- K894424DEVILBISS MODEL 7351 SERIES2Cleared 510(K)
- K894690CPAP MASK2Cleared 510(K)
- K893388DEVILBISS MODEL 7351D REVITALIZER CPAP SYSTEM2Cleared 510(K)
- K891540EDENTEC MODEL 2860 PRESSURE METER2Cleared 510(K)
- K883825MODIFIED SANDERS BI-PAPEASY2Cleared 510(K)
- K882219P.E.E.P. VALVE2Cleared 510(K)
- K881833NASAL CPAP SYSTEM2Cleared 510(K)
- K882292SULLIVAN NASAL CPAP SYSTEM2Cleared 510(K)
- K881614MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER)2Cleared 510(K)
- K880161ACKRAD PEDIATRIC C.P.A.P. SYSTEM2Cleared 510(K)
- K875073BREATHE-FREE2Cleared 510(K)
- K874479MC/CPAP MANIFOLD2Cleared 510(K)
- K873170ARIES2Cleared 510(K)
- K871693SLEEP APNEA NASAL CPAP SYSTEM2Cleared 510(K)
- K872202ADJUSTABLE PEEP VALVE2Cleared 510(K)
- K871523RESPIRONICS SANDERS BIPAPEASY2Cleared 510(K)
- K861758CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA2Cleared 510(K)
- K860848VITAL FLOW NASAL CPAP SYSTEM2Cleared 510(K)
- K861104VARIABLE HIGH FLOW DOWNS CPAP GENERATOR2Cleared 510(K)
- K854822LDS PEEP VALVE2Cleared 510(K)
- K854458CUSHION-FLEX TM-CPAP FACE MASK2Cleared 510(K)
- K851396SANDER'S MASKCPAP BY RESPIRONICS2Cleared 510(K)
- K851194AMBU CPAP SYSTEM2Cleared 510(K)
- K843889RESPIRONICS SLEEPEASY NASAL CPAP SYS2Cleared 510(K)
- K843835OHMEDA PEEP VALVE FOR GMS ABSORBER2Cleared 510(K)
- K834085DRAGER PEEP SYSTEM D2Cleared 510(K)
- K831503DOWNS ADJUSTABLE FLOW GENERATOR2Cleared 510(K)
- K831301PEEP SYSTEM D2Cleared 510(K)
- K830395PEEPER2Cleared 510(K)
- K820404PEEP VALVE2Cleared 510(K)
- K802943POSITIVE END EXPIRATORY PRESSURE VALVE2Cleared 510(K)
- K802707DRAGER PEEP CONTROL SYSTEM2Cleared 510(K)
- K802070VITAL SIGNS PEEP VALVE2Cleared 510(K)
- K800755BOEHRINGER LABS AMBULATORY PEEP VALVE2Cleared 510(K)
- K782152VALVE, AMBU PEEP2Cleared 510(K)
- K781332PEEP/CPAP VALVE2Cleared 510(K)
- K770766REGULATOR, PRESSURE, EXPIRATORY2Cleared 510(K)
- K760230VALVE, PEEP2Cleared 510(K)
- BYFMask, Oxygen, Low Concentration, Venturi1Product Code
- BYGMask, Oxygen1Product Code
- BYHDrain, Tee (Water Trap)1Product Code
- BYIPercussor, Powered-Electric2Product Code
- BYJUnit, Liquid-Oxygen, Portable2Product Code
- BYKTent, Oxygen, Electrically Powered2Product Code
- BYLTent, Oxygen1Product Code
- BYNChair, Posture, For Cardiac And Pulmonary Treatment1Product Code
- BYOBottle, Blow1Product Code
- BYPMouthpiece, Breathing1Product Code
- BYTVentilator, External Body, Negative Pressure, Adult (Cuirass)2Product Code
- BYWDevice, Rebreathing1Product Code
- BYXTubing, Pressure And Accessories1Product Code
- BZAConnector, Airway (Extension)1Product Code
- BZBCatheter, Nasal, Oxygen1Product Code
- BZDVentilator, Non-Continuous (Respirator)2Product Code
- BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer2Product Code
- BZOSet, Tubing And Support, Ventilator (W Harness)1Product Code
- BZRMixer, Breathing Gases, Anesthesia Inhalation2Product Code
- CADVaporizer, Anesthesia, Non-Heated2Product Code
- CAEAirway, Oropharyngeal, Anesthesiology1Product Code
- CAFNebulizer (Direct Patient Interface)2Product Code
- CAGCirculator, Breathing-Circuit2Product Code
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)1Product Code
- CALLaryngoscope, Non-Rigid1Product Code
- CAOAirway, Esophageal (Obturator)2Product Code
- CATCannula, Nasal, Oxygen1Product Code
- CAWGenerator, Oxygen, Portable2Product Code
- CAZAnesthesia Conduction Kit2Product Code
- CBFChamber, Hyperbaric2Product Code
- CBGSpreader, Cuff1Product Code
- CBHDevice, Fixation, Tracheal Tube1Product Code
- CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)2Product Code
- CBKVentilator, Continuous, Facility Use2Product Code
- CBLAbsorbent, Carbon-Dioxide1Product Code
- CBNApparatus, Gas-Scavenging2Product Code
- CBOAttachment, Intermittent Mandatory Ventilation (Imv)2Product Code
- CBPValve, Non-Rebreathing2Product Code
- MODAccessory To Continuous Ventilator (Respirator)2Product Code
- CCOBed, Rocking, Breathing Assist2Product Code
- CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)1Product Code
- CCTApplicator (Laryngo-Tracheal), Topical Anesthesia2Product Code
- CCWLaryngoscope, Rigid1Product Code
- EPEBrush, Cleaning, Tracheal Tube1Product Code
- FNCTent, Pediatric Aerosol2Product Code
- FOGHood, Oxygen, Infant1Product Code
- JAYSupport, Breathing Tube1Product Code
- JOHTube Tracheostomy And Tube Cuff2Product Code
- KFZHumidifier, Non-Direct Patient Interface (Home-Use)1Product Code
- KGBMask, Oxygen, Non-Rebreathing1Product Code
- KHAMask, Scavenging1Product Code
- LNZChanger, Tube, Endotracheal2Product Code
- MIANeedle, Spinal, Short Term2Product Code
- MNSVentilator, Continuous, Non-Life-Supporting2Product Code
- MNTVentilator, Continuous, Minimal Ventilatory Support, Facility Use2Product Code
- MRNApparatus, Nitric Oxide Delivery2Product Code
- MROApparatus, Nitric Oxide, Backup Delivery2Product Code
- MZTDevice, Heimlich Maneuver Assist2Product Code
- NFBConserver, Oxygen2Product Code
- NHJDevice, Positive Pressure Breathing, Intermittent2Product Code
- NHKResuscitator, Manual, Non Self-Inflating2Product Code
- NMATube, Tracheal, Reprocessed2Product Code
- NMCMask, Ventilator, Non-Continuous, Reprocessed2Product Code
- NMRNeedle, Spinal, Short Term, Reprocessed2Product Code
- NNHNeedle, Conduction, Anesthesia, Reprocessed2Product Code
- NOUContinuous, Ventilator, Home Use2Product Code
- NQYVentilator, Continuous, Minimal Ventilatory Support, Home Use2Product Code
- NVOSpacer, Direct Patient Interface2Product Code
- NVPHolding Chambers, Direct Patient Interface2Product Code
- NXATracheotomy Care Kit2Product Code
- OBNHumidifier, Respiratory, Mask (Direct Patient Interface)2Product Code
- OFQAnesthesia Kit2Product Code
- OFTSpinal Epidural Anesthesia Kit2Product Code
- OFUSpinal Anesthesia Kit2Product Code
- OFVRegional Anesthesia Kit2Product Code
- OGABrachial Plexus Anesthesia Kit2Product Code
- OGBCaudal Anesthesia Kit2Product Code
- OGCContinuous Brachial Plexus Block Tray2Product Code
- OGDCustom Anesthesia Tray2Product Code
- OGEEpidural Anesthesia Kit2Product Code
- OGFGlossopharyngeal Anesthesia Kit2Product Code
- OGGHumidifier Nebulizer Kit2Product Code
- OGHLaryngoscope Kit1Product Code
- OGINasal Endotracheal Tube Holder Kit1Product Code
- OGJNerve Block Tray2Product Code
- OGLOxygen Administration Kit2Product Code
- OLFMedevac Use Oxygen Generator2Product Code
- ONZMechanical Ventilator2Product Code
- OQUAirway Monitoring System2Product Code
- PHSOral Airway Assist1Product Code
- PMBExternal Airway2Product Code
- QAVHigh Flow/High Velocity Humidified Oxygen Delivery Device2Product Code
- QBYPositive Airway Pressure System2Product Code
- QCXRetrograde Intubation Set2Product Code
- OZRIntraoral Pressure Gradient Device2Product Code
- QFBIsocapnic Ventilation Device2Product Code
- Subpart G—MiscellaneousCFR Sub-Part
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K962492
- 510(k) Type
- Traditional
- Applicant
- NIDEK MEDICAL PRODUCTS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/23/1997
- Days to Decision
- 211 days
- Submission Type
- Statement